Regulatory affairs

Regulatory affairs

Registration of food supplements, border products, drugs and medical devices
Review and assessment of documentation received from the holder
Active communication with the holder to complete the documentation
Technical preparation of necessary local documents on behalf of the future holder
Drafting of SPC and PIL proposal
Maintenance of marketing authorization through variations and other changes in the approved data
Creation of an artwork proposal (mockup) where Macedonian packaging is needed
In agreement with the holder, services for delivery and collection of documentation on their behalf in the relevant institutions

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